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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name next generation sequencing based tumor profiling test
510(k) Number K202304
Device Name NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
NYU Langone Medical Center
240 E 38th Street
New York,  NY  10016
Applicant Contact Matija Snuderl
New York State Department of Health
Wadsworth Center, Empire State Plaza
P.O. Box 509
Albany,  NY  12237
Correspondent Contact Derek Symula
Regulation Number866.6080
Classification Product Code
Date Received08/14/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No